Valve coaptation measurement devices

ABSTRACT

Methods, systems, and coaptation measurement devices as described herein include an elongate sensor body at the end of a proximal connecting member, and a plurality of sensors in an array across a face of the sensor body, wherein each sensor of the plurality of sensors is configured to detect if a portion of a heart valve is in contact with the sensor.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a 371 U.S. National Phase of PCT/US2018/055920,filed on Oct. 15, 2018, which claims priority under 35 U.S.C. § 120 fromU.S. Provisional Application No. 62/572,034 filed on Oct. 13, 2017. Theentire contents of the priority applications are incorporated herein byreference.

TECHNICAL FIELD

This invention relates to the assessment of the coaptation height of aheart valve during surgery or another interventional procedure.

BACKGROUND OF THE INVENTION

Assessment of heart valve function is currently accomplished by avariety of modalities. In the evaluation of a patient with heart valvedisease, an echocardiogram is often the principle assessment tool forassessing the function of a heart valve. Each of the four major valves(the aortic valve, pulmonary valve, mitral valve, and tricuspid valve)have particular associated anatomical and functional characteristics. Asthese valves are assessed by echocardiogram, the degree of regurgitationor backward flow as well as stenosis or impairment to forward flow areimportant aspects of the valve function. Valves that are not functioningadequately may have one or more of several different mechanisms causingthe poor function. For valves that are regurgitant or leaking, a lack ofadequate and stable coaptation between adjacent heart valve leaflets isoften the fundamental reason for the leakage through the valve. Theexact mechanism for lack of adequate coaptation can vary and can includeissues with the support structure below the valve (the subvalvarapparatus), issues with leaflets, or issues with the support structurearound the valve (the annulus).

Coaptation is where the valve leaflets contact each other to create thevalve seal and it is expressed as coaptation height. This height refersto the distance over which adjacent valve leaflets touch each other toclose off the valve and prevent regurgitation through the valve. Thetaller the coaptation height, the better the valve will likely functionin the short and long-term. The coaptation height between two leafletscan vary along the entire coaptation surface between two leaflets of thevalve, and between different leaflet parings of the valves that havemore than two leaflets.

Assessment of the coaptation height prior to any intervention on thevalve has typically been done by echocardiogram. This is done with somefrequency in adult valves where the leaflet tissues are thicker andcoaptation height can be more easily imaged and often measured. Inpediatric heart valves, the leaflets are thinner, often making itdifficult to measure coaptation height by echocardiogram (ECHO),especially for the atrioventricular valves. Reports from adult andpediatric cardiac surgery literature cite the coaptation height as beingan important predictor of function after valve repair.

SUMMARY OF THE INVENTION

This disclosure relates to methods of assessing heart valves bymeasuring the coaptation height of the heart valve across the coaptationsurface. In some aspects, the disclosure relates to devices withmultiple sensors placed across the valve. The valve is then forced tocoapt either through passive testing by closing the valve under theforce of a fluid injected into the ventricle or aortic root, or bytesting the valve under normal physiologic circumstances with the heartbeating. The coaptation height of the valve is measured across one ormore points using multiple sensors integrated into the distal aspect ofthe device. The coaptation height is displayed for the user and the usercan track the coaptation height of the valve along one or more points onthe coaptation surface. The surgeon or operator may use the coaptationheight information to assess the valve for decision-making purposesregarding a possible intervention or for feedback regarding the adequacyof the valve before, during, or after valve repair surgery.

In one embodiment, a multisensor array on the distal aspect of thedevice is placed across the valve extending into the heart chamber orgreat vessel past the valve as well as extending into the heart chamberor great vessel proximal to the valve. The distal aspect of the devicemay be relatively rigid or may be flexible, even flexible enough to bedisplaced by the valve as it closes. The width of the distal aspect ofthe coaptation measurement device may be narrow such that only anumerical coaptation height is generated as information from the device.In another embodiment, the width of the distal aspect of place may beseveral millimeters or up to several centimeters wide and the coaptationheight of the valve is displayed as multiple numerical points as well asa graphical display of the coaptation height along the portion of thecoaptation surface which is measured.

The coaptation measurement device may be mounted in a catheter-baseddevice that can be placed across a valve during catheterizationprocedure while the heart is beating. In another embodiment, thecatheter-based coaptation device can be utilized during an operationwhere the surgeon passes it across a valve while the heart is beatingafter the patient has been weaned from a heart lung machine. Thecatheter-based coaptation measurement device can access all of the heartvalves and measure the coaptation height along the coaptation surface inone or more physiologic conditions. The coaptation measurement devicecan provide information for decision-making regarding possibleintervention or re-intervention for one or more of the heart valves.

In some embodiments, a coaptation measurement device includes anelongate sensor body at the end of a proximal connecting member, and aplurality of sensors in an array across a face of the sensor body,wherein each sensor of the plurality of sensors is configured to detectif a portion of a heart valve is in contact with the sensor.

Implementations can include one or more of the following: a plurality ofsensors are arranged across a second face of the sensor body. Eachsensor of the plurality of sensors has a width of a least a half of awidth of the elongate sensor body. The elongate sensor body is flexible.The elongate sensor body is between several millimeters and severalcentimeters wide. The plurality of sensors includes resistor elements ortemperature-sensing elements. The plurality of sensors includesfiberoptic elements or ultrasound elements. The array is a capacitorarray.

In some embodiments, a method of measuring a coaptation height of aheart valve across a coaptation surface includes placing a coaptationmeasurement device next to a coaptation surface, the coaptation devicecomprising: an elongate sensor body at the end of a proximal connectingmember, and a plurality of sensors in an array across a face of thesensor body. Each sensor of the plurality of sensors is configured todetect if a portion of a heart valve is in contact with the sensor,causing or allowing the valve to close, detecting which sensors of theplurality of sensors detect that the respective sensor is in contactwith the heart valve, and determining a coaptation height from thesensors.

Implementations can include one or more of the following: displaying thedetermined coaptation height. Repeating the placing, causing, detecting,and determining steps along one or more points on a coaptation surface.Displaying the determined height at each point on the coaptation surfaceas numerical values or as a graphical display. Causing the valve toclose comprises injecting fluid into a ventricle or aortic root. Theplurality of sensors includes resistor elements or temperature-sensingelements. The plurality of sensors includes fiberoptic elements orultrasound elements. The array is a capacitor array.

In some embodiments, a coaptation measurement system includes acoaptation measurement device, comprising an elongate sensor body at theend of a proximal connecting member; and a plurality of sensors in anarray across a face of the sensor body, wherein each sensor of theplurality of sensors is configured to detect if a portion of a heartvalve is in contact with the sensor, an extension member attachable tothe proximal connecting member, a handle connected to the extensionmember; and a display connected to the device, wherein the display isconfigured to show information detected by the sensors of the coaptationmeasurement device.

Implementations can include one or more of the following: the extensionmember is malleable or bendable. A plurality of sensors are arrangedacross a second face of the sensor body. Each sensor of the plurality ofsensors has a width of a least a half of the width of the elongatesensor body. The elongate sensor body is flexible. The plurality ofsensors includes resistor elements or temperature-sensing elements. Theplurality of sensors includes fiberoptic elements or ultrasoundelements. The array is a capacitor array.

The advantages and other features of the technology disclosed hereinwill become more readily apparent to those having ordinary skill in theart and the following detailed description of certain embodiments inconjunction with the drawings that set forth representative embodimentsof the present invention and wherein like reference numerals identifysimilar structural elements. It is to be understood that the subjecttechnology is not intended to be limited to the particular constructsand methods described in the described embodiments, as one skilled inthe art can extend the concepts involving involved using variations thatare obvious after reading the present disclosure. All publications,patent applications, patents, and other references mentioned herein areincorporated by reference into their in their entirety. In the case ofconflict, the present specification, including definitions, willcontrol. In addition, the materials methods, and examples areillustrative only and not intended to be limiting. All relativedescriptions herein, such as top, bottom, left, right, up, and down arewith reference to the figures, and not meant to be in a limiting sense.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a view of a mitral valve from the perspective of the leftatrium looking towards the left ventricle.

FIG. 1B is a cross-sectional view of the left ventricle with mitralvalve leaflets and subvalvar apparatus.

FIG. 1C is a cross-sectional view of a mitral valve during diastole.

FIG. 1D is a view of an aortic valve from the perspective of the aorticroot looking down toward the left ventricle.

FIG. 1E is a cross-sectional view of the aortic valve and aortic root.

FIG. 1F is a cross-sectional view of an aortic valve and aortic root.

FIG. 2A is a cross-sectional view of a mitral valve and subvalvarapparatus with a coaptation measurement device across the valve.

FIG. 2B is a view of the mitral valve from the perspective of the leftatrium with a coaptation measurement device across the valve.

FIG. 2C is a view of the mitral valve from the perspective of the leftatrium with a coaptation measurement device across the valve.

FIG. 2D is a cross-sectional view of an aortic valve and ascending aortawith the coaptation measurement device across the valve.

FIGS. 2E-2F are views of the aortic valve from the perspective of theaortic root with the coaptation measurement device across the valve.

FIG. 3A-3C show the sensor portion of a coaptation measurement device.

FIG. 3D is a view of the mitral valve from the perspective of the leftatrium with a flexible coaptation measurement device across the valve.

FIG. 4A is the distal portion of a coaptation measurement device with aproximal extension portion and a handle.

FIG. 4B is the distal portion of the coaptation measurement device witha proximal extension portion.

FIG. 5 is a coaptation measurement device with associated displayscreen.

FIG. 6 is a cross-sectional image of a heart with a coaptationmeasurement catheter across the mitral valve.

DETAILED DESCRIPTION

The present disclosure overcomes many of the challenges associated withmeasurement of coaptation height in the assessment of heart valves usingknown methods. The coaptation measurement devices described herein areplaced across a heart valve during a catheterization procedure or opensurgical assessment of the valve. The coaptation measurement devices canquantify the coaptation height of the valve along the coaptation surfaceof the valve. This coaptation height measurement can be assessed alongthe coaptation surface of the valve to determine various aspects of thevalve and provide valuable information for the cardiologist in thecatheter lab or the surgeon who is assessing and/or repairing the heartvalve. Coaptation height information may be used to guide as well asadjust and assess the adequacy of a valve intervention.

Assessment of coaptation height during surgery while a valve is beingactively repaired has been limited to qualitative approaches, frequentlyinvolving staining exposed leaflets with ink and assessing otherportions of the valve that remain unstained. These techniques are notapplicable to all valves and have some inherent limitations. Priorqualitative methodology of assessing valves during repairs as part ofopen-heart surgery often involves a qualitative assessment of theability the valve to prevent saline from leaking through a ventricle.During testing of an atrioventricular valve while the heart is open,saline or a similar buffered crystalloid solution is injected into theventricle to distend the ventricle and close the valve. This is referredto as passive testing. For aortic valve repairs, the aortic root isfilled and the coaptation of the valve qualitatively assessed albeitwith very low pressure. These methodologies do not give any assessmentof quantitative coaptation height along the portion of the valve.Although coaptation height is fundamental to the function of the valveand in some reports is predictive of later outcome of valve function, itis difficult to assess during an operation or another interventionalprocedure.

Referring to FIG. 1A, a mitral valve 10 is shown as viewed from the leftatrium. The mitral valve 10 has an anterior leaflet 12 and posteriorleaflet 14. The anterior 12 and posterior 14 leaflets press against eachother during systole as a left ventricle squeezes to preventregurgitation of blood from the left ventricle into the left atrium.Referring to FIG. 1B, a cross-sectional image of the left ventricle isshown, with left ventricular wall 18 and left ventricular cavity 17, andwith the anterior leaflet of the mitral valve 12 and posterior leafletof the mitral valve 14 separating the left ventricle from the leftatrium. The cord support structures of the mitral valve leaflets 16 areessential for the normal function of the mitral valve. The degree towhich the anterior-posterior leaflets touch each other as a valve closesthe coaptation of the valve. The coaptation can be measured as acoaptation as shown by arrow 20 in FIG. 1B.

Referring to FIG. 1C, the anterior leaflet of a mitral valve 12 andposterior leaflet 14 may be altered from their normal function such thatone or the other of the leaflets does not come to the middle and coaptnormally. This may result in a difference in the amount of the valveleaflet material available for coaptation. This may result in one valveleaflet, such as the anterior leaflet 12, having a potential coaptationheight shown by arrow 22 while the posterior leaflet 14 has a potentialcoaptation height that is different shown by arrow 24. As heart valvesare being assessed either prior, during, or after a valve interventionor repair, knowing both the height of actual coaptation where the valveleaflets touch each other (spanned by arrow 22) as well as the availablevalve leaflet material for coaptation (spanned by arrow 24) for theposterior leaflet in the event that they are different is very useful.This is very useful information in assessing and eventually interveningon a valve.

Referring to FIG. 1D, an aortic valve is shown as viewed from the aorticroot looking down towards the left ventricle. This aortic valve 40 hasthree valve parts, which are leaflets 42, 44, 45 and which areconstrained by the aortic root wall 46. Referring to FIG. 1E, across-section of the aortic valve, valve leaflets 42 and 44 areconstrained by the aortic root wall 46. The height of coaptation of theadjacent aortic valve leaflets 42 and 44 is shown as a measurable height50. Referring to FIG. 1F, a cross-sectional view of an aortic valve withleaflets 42 and 44 demonstrates various potential heights 52 and 54 thatmay result in a functional coaptation height of the valve depending onhow the valve is intervened upon. In this current valve, the functionalor actual coaptation height would be 52.

FIG. 2A shows a mitral valve in cross-section with anterior leaflet 12and posterior leaflet 14, with subvalvar chordal attachments 16, andwith a coaptation measurement device 70 with an elongated distal portion72. The coaptation measurement device 70 is positioned across the mitralvalve between leaflets 12 and 14, with its distal end 72 arranged withinthe left ventricle.

The coaptation measurement device 70 is placed across a heart valveduring a catheterization procedure or open surgical assessment of thevalve. The coaptation measurement device 70 can quantify the coaptationheight of the valve by assessment of the coaptation surface of thevalve. This coaptation height measurement can be assessed along thecoaptation surface of the valve across the aspects of the valve toprovide valuable information for the cardiologist in the catheterizationlab or the surgeon who is assessing and/or repairing the heart valve.Coaptation height information can be used to guide as well as adjust andassess the adequacy of a valve intervention.

The coaptation measurement device 70 has sensors built into the deviceto assess the degree of coaptation of the valve in the area of the valveacross which the device was placed. By differentiating between the leftatrium, the coaptation portion of the valve, and the left ventricle, theheight of coaptation can be measured. The coaptation measurement device70 can have sensors on one or both sides to assess the valve coaptationheight. If there are sensors on both sides, the valve coaptation heightcan be assessed as the smaller of the coaptation height of each leaflet.A leaflet with a taller height can be viewed as potential for morecoaptation if the valve leaflets were to be moved in by some valveintervention.

Referring to FIG. 2B, a mitral valve 10 is shown from the perspective ofthe left atrium looking toward the left ventricle. The anterior leaflet12 and posterior leaflet 14 have a coaptation measurement device 70shown in cross-section, which extends between the anterior leaflet 12and posterior leaflet 14. The coaptation measurement device 70 can beused to assess coaptation height over a portion of the valve. Referringto FIG. 2C, the coaptation device shown in cross-section 70 ispositioned between the anterior leaflet 12 and posterior leaflet 14 on adifferent portion of the mitral valve than is shown in FIG. 2B. It isimportant for the surgeon to know the coaptation height of a heart valvealong the entire coaptation surface of the heart valve. Measurement ofcoaptation height over one portion of the valve may be adequate, butinadequate over another portion, and the latter may be the site ofregurgitation of the valve. In the event that the coaptation measurementdevice 70 has a width less than the entire coaptation length of thevalve, the coaptation device 70 can be moved to assess the valve invarious locations to get an adequate or even complete picture of thecoaptation height along the entire valve. For example, the coaptationmeasurement device 70 can have a maximum width of 18 mm to 23 mm inwidth to fit the mean diameter of the male aortic root. The coaptationmeasurement device 70 can be less than a typical valve width, forexample less than 15 mm, less than 10 mm, or less than 5 mm, and bemoved to assess the valve in various locations.

Referring to FIG. 2D, the root of the aorta is shown in cross-sectionwith aortic valve leaflets 42 and 44 and aortic root wall 46. Thecoaptation measurement device 70 is positioned across the aortic valvewith the distal end 72 residing within the left ventricle. Thecoaptation device may assess the coaptation height of the aortic valveleaflets in one or more portions of the valve. The coaptation device canbe used to assess the valve during a catheterization procedure while theheart is beating during diastole when the heart is filling and theaortic valve is closed. The coaptation measurement device can also beused during an open procedure where a valve is assessed by filling theaortic root with fluid and inducing coaptation of the aortic valveleaflets in a pressurized or unpressurized fashion to assess the heightof coaptation.

Referring to FIG. 2E, the aortic valve 40 is shown with the leaflets 42,44, and 45. The coaptation measurement device 70 is shown incross-section positioned across the aortic valve between aortic valveleaflets 42 and 45, assessing a portion of the coaptation plane betweenthe leaflets 42 and 45. The coaptation measurement device 70 may need tobe moved to assess the coaptation height over several areas to assessthe entire coaptation plane between two valve leaflets.

Referring to FIG. 2F, the aortic valve 40 is shown with the coaptationmeasurement 70 shown in cross-section position between two aortic valveleaflets 44 and 45. Certainly for tri-leaflet aortic valves andpulmonary valve or, less commonly for bi-leaflet or quadra-cusped aorticor pulmonary valves, assessment of multiple coaptation planes may benecessary to fully assess the coaptation height of the valve. Thecoaptation height of the valve will change with valve intervention. Thedevice may be used multiple times throughout the interventionalprocedure or an open surgical procedure to reassess the coaptationheight. The coaptation device 70 may be used to adjust the coaptation ofthe valve and calibrated to the desired amount by changing the anatomy.This could include a wide variety of interventions on any of the heartvalves including changes to the valve subvalvar, valvar, annular, andeven super annular aspects of the valve.

Shown in FIG. 3A from the front and side is a coaptation measurementdevice 70 with a distal end 72 and a proximal connecting member 74. Animportant aspect of the coaptation measurement device 70 is the one ormore sensors 80 positioned on the face 71 of the device along itslength. The coaptation measurement device 70 may have an aspect ratiothat is less than 1:1, giving a dimension of the thickness of the device76 less than the width of the device. The smaller the thickness 76 ofthe device, the smaller is the distortion of the valve leaflets thatwill occur during assessment of coaptation height.

The one or more sensors 80 positioned along the face of the device 71are used to assess the portion of the coaptation device that is adjacentto the space above the valve, the area of coaptation, and the spacebelow the valve. For the different valves, the spaces above and belowthe valve represent different chambers of the heart or great vessels. Inone embodiment of the invention, the sensor 80 consists of multipleresistor elements positioned across the device, creating an array ofsensors. These resistor elements can be used with a computer interfaceto calculate the various resistances on the sensor and measure thecoaptation height of an adjacent leaflet pressing against the sensor.The sensors 80 can also be a capacitor array forming a capacitive touchsensor capable of assessing the area of coaptation of the adjacentleaflet in the areas above and below the leaflet. These sensors can betemperature-sensing elements including thermistors to assess thetemperature at the one or more spots along the length of the sensor. Asthe leaflets press against the sensor, a portion of the temperaturesensor elements can be at a sufficiently different temperature than theother temperature elements to assess the coaptation area and height ofadjacent valve leaflet. Typically, during open-heart surgery, the valveis assessed by injecting a fluid across the valve.

Monitoring the temperature changes as the valve leaflet coapt againstthe device can also be used to indicate the coaptation height. Thesesensors 80 can be optical elements that sense the presence of anadjacent structure with different optical density than blood or salineto assess the area of the sensor that is adjacent a portion of the heartvalve leaflet for measurement of coaptation height. The sensor may becomprised of fiberoptic elements that may be coupled with a light sourceand camera or other sensor to receive and analyze the signals from thefiberoptic elements. The sensor may contain one or more than onedifferent types of sensors described herein. For example, the sensor maymeasure force and have optical elements that sense optical changes. Theforce and optical data could be collaborated to provide data regardingthe valve function. Alternatively, the sensor elements 80 can beultrasound elements that send and receive ultrasound signals. Theultrasound signals delivered to the area adjacent a specific one of thesensors 80 can indicate an area of the sensor that is adjacent to aportion of a valve leaflet. The ultrasound elements can be in one of avariety of forms including but not limited to multiple individualcrystals, arrays or sets of arrays of crystals or a piezoelectric filmsuch as the film produced by Kureha (NY, N.Y.).

The sensors 80 may contain a doping agent that transfers a substance tothe valve leaflet where it contacts the sensor. The portion of the heartvalve leaflet that touched the sensor then can be imaged to assess thecoaptation height. An example would be a sensor 80 that has anultraviolet substance attached, e.g., adhered, etched, or coated. Afterthe coaptation device 70 is placed in proximity to the valve leaflets tobe tested, the portions of the heart valve leaflet that touched sensors80 would be imaged with a UV light and a camera capable of capturing UVspectrum light to detect the areas of the heart valve that touched thecoaptation measurement device.

The sensor elements may be one or more rows of sensor elements (eitheralong the length or along the width of the device) or an array of sensorelements across the face 71 of the device. There also may be sensorelements on the side of the device (e.g., along its width 76). In oneembodiment, the sensor technology may be a matrix of a resistive touchsensor technology. Tekscan, Inc. (Boston, Mass.) has a representativeresistive sensor technology suitable as a sensor for this device. Thistechnology has a multiple array of resistive sensors that may beoptimized to have distance between adjacent sensor points of less than a2 mm or in another preferred embodiment less than 1 mm or in anotherpreferred embodiment less than half a millimeter between one or more thesensors for points of measurement. Using this resistive array typesensor, the coaptation can be measured with adequate granularity toinform the surgeon of the adequacy of coaptation height or if additionaladjustments need to be made. The resistive array sensor may becalibrated to measure the force of the leaflets on the sensor. The forcemeasurements may be sensed many times per second creating a dynamicforce map of the coaptation of the valve. The force measured across thesensor as the leaflets coapt can be translated into the coaptationheight of the valve. The specifics of the leaflet forces across thecoaptation height of the valve and how those forces develop dynamicallyduring systole may be used to further characterize the function of thevalve and understand current valve function and predict the valvefunction in the future. Analysis of the dynamic forces generated duringcoaptation may be displayed to the physician for additional decisionmaking on the function of the valve in addition to the coaptationheight. Referring to FIG. 3B, this coaptation measurement device 70 withdistal portion 72 and proximal connecting member 74 may have one or moresensor elements 82 that extend across a portion of the face 71 of thesensor (e.g., extend across its width). The sensor elements may have awidth of one-half or more of the width of the face 71 of the device.

Referring to FIG. 3C, in one embodiment, device 90 has a distal portion92 and proximal connecting member 94, one or sensor elements 80, and across-sectional thickness 96 minimal dimension. The material from whichthe sensors or the coaptation measurement device 90 is constructed maybe a thin, flexible material. The heart valve leaflet structures arethin and very flexible, especially heart valves in children and infants.A flexible coaptation measurement device 90 that can conform to theheart valve leaflets in the region of the coaptation to be assessed mayfacilitate accurate assessment of the coaptation height by eliminatingor minimizing any distortion of the heart valve leaflets.

Referring to FIG. 3D, a mitral valve is shown with leaflets 12 and 14,and a coaptation measurement device 90 shown in cross-section. Thedevice 90 is flexible and is assessing the coaptation height between theanterior 12 and posterior 14 leaflets of the mitral valve around aportion of the valve, which is curved. The flexible coaptationmeasurement device 90 may allow a wider device to be used, which canassess the coaptation height over a wider coaptation surface of thevalve.

In FIG. 4A, the coaptation measurement device 70 has a distal end 72,and the proximal connecting member 74 is connected to an extensionmember 100, which connects to a handle 110. Flexible device 90equivalently could be used. From handle 110, an electrical cord 112extends to connect to a display and control element. The extensionmember 100 extends from the handle 110 and may be linear or nonlinear inshape. In one embodiment, the extension 100 may be malleable or bendableso the surgeon could adjust the extension member 100 to position thesensor-containing portion of the coaptation measurement device 70 acrossthe valve in a way so as to visualize but also comfortably hold so as tonot distort the valve. The proximal connecting member 74 may be veryshort or could have some length (e.g., more than 1 cm, more than 2 cm,more than 5 cm) to maximize the ability for the surgeon to position thesensor portion across the valve in a way to visualize and not distortthe valve.

Referring to FIG. 4B, in another embodiment, the sensor-containingcoaptation measurement device 70 has proximal connecting member 102which is continuous with an extension member 100. This proximalconnecting member 102 may be very flexible in nature. The goal is tominimize any impact of distortion of the valve on the assessment of thecoaptation of the valve. In one embodiment, the proximal connectingmember 102 may be a small cable carrying electrical signals from thesensor-containing portion of the device or it may be a thin ribbon-likestructure that is flexible and confers very little force betweenextension 100 and distal coaptation measuring portion 70.

In another embodiment, the extension member 100 may be mounted to achest retractor or other device such as a stand mounted to the operatingroom table. This arrangement would allow fixation of the device suchthat it could be set so the sensor-containing portion of the device 70was across the valve without motion of distortion the valve duringpassive testing of the valve.

Now referring to FIG. 5 , the sensor-containing portion of thecoaptation measurement device 70 is connected to the extension member100. This extension member may have a separate handle portion at itsproximal end. A cord or electrical wire-containing device 112 connectsthe device to computer interface 120 consisting of at least one screen122. This interface 120 allows the surgeon or other operators to assessthe coaptation height of any of the valves within the heart. Theoperator can select which valve is being assessed and mark the locationof each assessment point on the valve. The operator can measure multiplecoaptation heights for each valve. These multiple coaptation heights canthen be graphically and numerically displayed on the screen 122. Thisdisplay will give the surgeon or other operator a picture of coaptationheights across the entire coaptation length of the valve. Depending onthe width of the sensor-containing portion of the coaptation measurementdevice, each coaptation measurement may be displayed either as anumerical height or as a range of heights in a graphical display of thecoaptation length along the length of the sensor portion of the device.

The surgeon can utilize these data to make a decision to adjust thevalve further with additional repair techniques to alter the coaptationheight until the minimum goal coaptation is met. The coaptation heightof one or more portions of the valve can be retested after additionalvalve repair maneuvers. The final testing of the valve coaptation can becompleted prior to closing the heart. After the patient is weaned offcardiopulmonary bypass, the function of the valve can be assessed andcompared to the measured coaptation height. It is expected that thecoaptation heights obtained during intraoperative measurements willcorrespond to the valve function once the patient is off cardiopulmonarybypass and may be a predictor of the short and long-term valve function,with higher coaptation heights corresponding to better long-term valvefunction. For valve repair techniques that require fine adjustmentincluding use of artificial cords, annuloplasty, and commissuroplastymaneuvers, the valve coaptation height measurement device may prove veryuseful for fine-tuning these various valve repair techniques for thebest possible outcome.

Referring to FIG. 6 , a cross-sectional image of the heart 200 is shownwith inferior vena cava 210, right atrium 212, left atrium 214, andinteratrial septum 216. The left ventricular wall 18 with left ventriclecavity 17 is shown with the mitral valve anterior leaflet 12 andposterior leaflet 14 with a coaptation measurement device 144 with adistal end 148 projecting through the mitral valve. A proximalconnecting member 142 extends from the body of the catheter 140, whichmay enter the heart from the veins of the lower body. In one embodiment,the catheter may enter the femoral vein, pass through the inferior venacava and right atrium, across the atrial septum through the left atriumand across the mitral valve. The catheter-based coaptation measurementdevices allow for measurement of the mitral valve coaptation heightwhile the patient's heart is beating during a catheterization procedure.There are multiple ways to access each of the heart valves duringcatheterization. This is one embodiment of a catheter path crossing themitral valve. There may be other routes from the catheter to cross themitral valve including via the superior vena cava. The tricuspid valvecan also be assessed via the superior or inferior vena cava than acrossa tricuspid valve. The catheter can be extended through the rightventricle across the pulmonary valve to assess the coaptation height ofthe pulmonary valve. Additionally the catheter could be extendedantegrade or retrograde across the aortic valve to assess the coaptationheight of the aortic valve.

The use of the coaptation measurement device may be coupled withsimultaneous transesophageal or transthoracic echocardiogram imaging toassess the exact location of the coaptation measurement device withinthe valve. With the combination of fluoroscopy as well asechocardiography, multiple coaptation heights for each valve could beassessed with known location of the coaptation device across theparticular portion of the valve, thereby giving a picture of thecoaptation heights across the coaptation surface for each valve ofinterest in a particular patient. Utilizing a catheter-based embodimentof the coaptation measurement device, the coaptation heights for abeating heart can be assessed. The physiologic conditions of the patientcould also be altered to assess the valve under various conditions. Thiscould include either giving volume to or diuresing a patient or addingor removing inotropic support as two examples of how the physiology of apatient can be changed to assess the function of the valve underdifferent physiologic states during a catheterization procedure. Thesensor portion of the coaptation measurement device 144 can be ofsufficiently narrow width to fit through standard catheter sizes of 4,6, 8, 10, 12, or 14 French. Alternatively, the sensor-containing portionof the catheter 144 can be in a rolled, folded, or otherwise reducedwidth state that can be expanded after it is advanced from withincatheter 140 while the catheter is within the heart. The width of thesensor-containing portion of the catheter 144 may be wider than thewidth of the catheter 144 to allow measurement of coaptation height overa wider distance of a heart valve.

Other Embodiments

It is to be understood that while the invention has been described inconjunction with the detailed description thereof, the foregoingdescription is intended to illustrate and not limit the scope of theinvention, which is defined by the scope of the appended claims. Otheraspects, advantages, and modifications are within the scope of thefollowing claims.

What is claimed is:
 1. A coaptation measurement device comprising: anelongate sensor body at the end of a proximal connecting member; and aplurality of sensors in an array across a face of the sensor body,wherein each sensor of the plurality of sensors is configured to detectif a portion of a heart valve is in contact with the sensor, and whereinthe plurality of sensors is configured to assess the valve coaptationheight.
 2. The coaptation measurement device of claim 1, wherein aplurality of sensors are arranged across a second face of the sensorbody.
 3. The coaptation measurement device of claim 1, wherein eachsensor of the plurality of sensors has a width of a least a half of awidth of the elongate sensor body.
 4. The coaptation measurement deviceof claim 1, wherein the elongate sensor body is flexible.
 5. Thecoaptation measurement device of claim 1, wherein the elongate sensorbody is between several millimeters and several centimeters wide.
 6. Thecoaptation measurement device of claim 1, wherein the plurality ofsensors includes resistor elements or temperature-sensing elements. 7.The coaptation measurement device of claim 1, wherein the plurality ofsensors includes fiberoptic elements or ultrasound elements.
 8. Thecoaptation measurement device of claim 1, wherein the array is acapacitor array.
 9. A method of measuring a coaptation height of a heartvalve across a coaptation surface, the method comprising: placing acoaptation measurement device next to a coaptation surface, thecoaptation device comprising: an elongate sensor body at the end of aproximal connecting member; and a plurality of sensors in an arrayacross a face of the sensor body; wherein each sensor of the pluralityof sensors is configured to detect if a portion of a heart valve is incontact with the sensor, and wherein the plurality of sensors isconfigured to assess the valve coaptation height; causing or allowingthe valve to close; detecting by computer or a control element whichsensors of the plurality of sensors detect that the respective sensor isin contact with the heart valve; determining, by the computer or thecontrol element, a coaptation height from the sensors; and displayingthe determined coaptation height.
 10. The method of claim 9, furthercomprising repeating the placing, causing, detecting, and determiningsteps along one or more points on a coaptation surface.
 11. The methodof claim 9, further comprising displaying the determined height at eachpoint on the coaptation surface as numerical values or as a graphicaldisplay.
 12. The method of claim 9, wherein causing the valve to closecomprises injecting fluid into a ventricle or aortic root.
 13. Themethod of claim 9, wherein the plurality of sensors includes resistorelements or temperature-sensing elements.
 14. The method of claim 9,wherein the plurality of sensors includes fiberoptic elements orultrasound elements.
 15. The method of claim 9, wherein the array is acapacitor array.
 16. A coaptation measurement system, comprising: acoaptation measurement device, comprising: an elongate sensor body atthe end of a proximal connecting member; and a plurality of sensors inan array across a face of the sensor body; wherein each sensor of theplurality of sensors is configured to detect if a portion of a heartvalve is in contact with the sensor, and wherein the plurality ofsensors is configured to assess the valve coaptation height; anextension member attachable to the proximal connecting member; a handleconnected to the extension member; and a display connected to thedevice, wherein the display is configured to show information detectedby the sensors of the coaptation measurement device.
 17. The coaptationmeasurement system of claim 16, wherein the extension member ismalleable or bendable.
 18. The coaptation measurement system of claim16, wherein a plurality of sensors are arranged across a second face ofthe sensor body.
 19. The coaptation measurement system of claim 16,wherein each sensor of the plurality of sensors has a width of a least ahalf of the width of the elongate sensor body.